My source sm and csl behring assurance sm are service marks of csl behring llc. Wolf, senior director of global clinical safety and pharmacovigilance at csl behring, considers oracle argus state of the. The analysis comprises reports of potential adverse drug reactions adrs from all sources, reported as part of routine pharmacovigilance at csl behring. Sections or subsections omitted from the full prescribing information are not listed.
Csl behring commitment csl behring is committed to patients in many ways. During the year, csl plasma initiated a crosssite collaboration to harmonise the plasma supply chain processes, remove redundancies and. Csl limited abn 99 051 588 348 our corporate responsibility 20 3. Sep 18, 2019 resources at csl behring available to the patient. Alpha 1 proteinase inhibitor human, zemaira is contraindicated in patients with a history of severe systemic reactions to the product or to a 1 pi protein, including anaphylaxis. Csl plasma, a division of csl behring, operates one of the worlds largest plasma collection networks, providing human plasma to csl behring for the manufacture and distribution of.
To report suspected adverse reactions, contact csl behring pharmacovigilance at 18669156958 or fda at 1800fda1088 or. Thrombosis may occur with immune globulin products, including privigen. Susan welsh, chief safety officer, csl behring panellists. Csl behring trusts oracle argus for pharmacovigilance.
Hsa albumin inquiries human serum albumin hsa csl behring. Csl behring immune globulin intravenous human, 10%. Drug interactionsthe passive transfer of antibodies may interfere with the response to live virus vaccines, and. Aug 22, 2019 report any infections thought to be possibly transmitted by rhophylac to csl behring pharmacovigilance at 18669156958. Beverley worrall pharmacovigilance regions specialist. Over the reporting year, under the leadership of csls global clinical.
Riastap is indicated for the treatment of acute bleeding episodes in patients with congenital fibrinogen deficiency, including afibrinogenemia and hypofibrinogenemia learn more. Csl behring brief summary of prescribing information hizentra. Haegarda for the prevention of hereditary angioedema hae. If you do not have adobe reader, download it from the adobe website. This descriptive study analysed postmarketing safety reports recorded in the csl behring pharmacovigilance database from january 1986 to december 20. This chapter discusses the past, present and future of the. Find csl behring pharmacovigilance jobs on glassdoor.
Humatep provides bleed control across all vwd types. Pdf detect risks earlier, reduce costs, and increase. Contact csl behring to receive more product information. United kingdoms spontaneous reporting scheme, commonly known as the yellow card scheme, is the cornerstone of the monitoring process. Csl behring immune globulin intravenous human, 10% liquid.
Oracle argus is the marketleading solution for processing, analyzing, and reporting adverse event cases originating in pre and postmarket drugs, biologics, vaccines, devices, and combination products. Every day at csl behring, we work as if someones life depends on it, because it does. Like csl behring, these third parties will not rent. Thus, there must always be one qualified person responsible for pharmacovigilance at european union level, but there may be a need for additional nominated. Riastap prescribing information riastap fibrinogen concentrate. Use the easy dosing calculator or download the pdf. In order to view pdf documents, you must have adobe reader software installed on your computer. To report suspected adverse reactions, contact the csl behring pharmacovigilance department at 18669156958 or. Berinert is the only c1 esterase inhibitor c1inh approved for ondemand treatment of acute abdominal, facial, or laryngeal attacks of hae in adults and children. In some cases, csl behring uses third parties under contract with csl behring to administer our educational and patient benefit programs.
Pharmacovigilance is also known as drug safety and is defined by the world health organization as the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drugrelated problems 1,2. Dailymed haegarda c1 esterase inhibitor subcutaneous human. Reactions, contact the csl behring pharmacovigilance department at 18669156958 or. Mix2vial transfer set reconstitution at a glance brochure the mix2vial reconstitution brochure provides stepbystep guidance on reconstitution for zemaira. Report an undesirable effect by country csl behring. Csl behring albumin human 5% solution alburx 5 only description alburx 5, albumin human 5% solution is a sterile aqueous solution for intravenous administration containing the albumin component of human blood. Pharmacovigilance department at 18669156958 or fda at 1800fda1088. About riastap riastap is a lyophilized fibrinogen concentrate for reconstitution. Improve the inspection experience gmp inspections and pharmacovigilance effectively address inspection observations on the threshold of product quality and pharmacovigilance christoph hoeck, ph. Do not use haegarda to treat an acute hae attack once it starts. Csl behring drives more than 85% of overall company revenue with substantial markets in asia pacific, europe and north america. Utilize emerging technologies and innovative methods to. Inspiration challenge initiatives to build pv capacity in emerging markets have resulted in an explosion of global pv legislation.
A healthcare professional can teach you to selfadminister haegarda for prophylaxis. Safety and pharmacovigilance gcsp function, multiple audits and inspections by. Corporate responsible business practice csl behring norge. Haegarda is a plasmaderived concentrate of c1 esterase inhibitor human. However, i understand that the csl behring entities will disclose my personal health information for the limited purposes. Csl behring provides a broad range of resources and materials to assist physicians in the treatment of alpha1.
Haegarda, c1 esterase inhibitor subcutaneous human, is an injectable medicine used to prevent swelling andor painful attacks in adults and adolescents with hereditary angioedema hae. You can also report side effects to csl behring s pharmacovigilance department at 18669156958. Learn how privigen treats pi, chronic itp, and cidp, and get helpful tips on living with these conditions. Pharmacovigilance an overview sciencedirect topics. Csl behring csl behring is a global leader in developing and delivering high quality medicines that. To report suspected adverse reactions, contact the csl behring pharmacovigilance department at 18669156958 or fda at 1800fda1088.
Zemaira alpha1proteinase inhibitor human hcp website. Csl behring 1020 first avenue po box 61501 king of prussia, pa 194060901 tel 610 878 4000 csl behring is committed to its promise to improve the quality of life for patients with rare and serious diseases. Volume 9 pharmacovigilance medicinal products for human use and veterinary medicinal products ref. Pdf introduction to pharmacovigilance researchgate. Berinert is a plasmaderived c1 esterase inhibitor human indicated for the. Due to the risk of severe hypersensitivity, zemaira is also contraindicated in immunoglobulin a. Please see full prescribing information for haegarda, including the patient product information. We provide routine surveillance of the safety of our medications. Report all infections thought to be possibly transmitted by hizentra to csl behring pharmacovigilance at 18669156958. We manufacture remedies for serious and rare diseases.
We have an extensive pharmacovigilance program and are. When contacting you on behalf of csl behring about these programs, these third parties will have access to your email address, address, andor phone number. We have a high quality and potentially valuable portfolio of projects in various stages of development. Wolf, senior director of global clinical safety and pharmacovigilance at csl. About congenital fibrinogen deficiency congenital fibrinogen deficiency cfd is a rare inherited bleeding disorder in which the bodys ability to form blood clots is impaired. Pharmacovigilance sourcing including plasma collection csl s values of code of responsible business practice. Do not administer to the newborn infant see pediatric use 8. Csl behring 1020 first avenue po box 61501 king of prussia, pa 194060901 tel 610 878 4000 csl behring is committed to its promise to improve the quality of. Highlights of prescribing information these highlights do not include all the information needed to use humatep safely and effectively. It starts with the molecules our scientists study, test, and develop into therapies, progresses through the manufacturing process into the shipping and storing of our medicines, and ends in the bodies of our patients, helping them to live fuller and longer lives.
If you do not have adobe reader, download it from the adobe web site. Suspected adverse reaction report form for csl products. Due to the risk of severe hypersensitivity, zemaira is also contraindicated in immunoglobulin adeficient patients with antibodies against iga. Do not use berinert, c1 esterase inhibitor human, if you have experienced lifethreatening allergic reactions or severe hypersensitivity to the product. This product is prepared from the plasma of us donors. Pop out the control panel located in the upper right of your screen type your question into the question box. The analysis comprises reports of potential adverse drug reactions adrs from all sources, reported as part of routine pharmacovigilance at csl. Antihemophilic factorvon willebrand factor complex human, humatep is approved to treat and prevent bleeding in adult patients with hemophilia a classical hemophilia. Wolf, senior director of global clinical safety and pharmacovigilance at csl behring, considers oracle argus state of the art and best in class for managing medicinal product safety. Csl behring is committed to helping you and your patients by providing valuable live support with billing, insurance, and financial assistance needs. Haegarda is a plasmaderived concentrate of c1 esterase inhibitor human c1inh. Adverse drug reaction adr reports were compiled from june 1, 1993 to september 30, 20 as part of the ongoing csl behring routine pharmacovigilance. Diversity and inclusion are top priorities for csl behring. Pharmacovigilance department at 18669156958 or to the fda at 1800.
Suspected adverse reaction report form csl behring pharmacovigilance p. To report suspected adverse reactions, contact csl behring pharmacovigilance at 1 8669156958 or fda at 1800fda1088 or. Csl behring full prescribing information berinert c1 esterase inhibitor human freezedried powder 1 indications and usage berinert is a plasmaderived concentrate of c1 esterase inhibitor human indicated for the treatment of acute abdominal, facial, or laryngeal hereditary angioedema hae attacks in adult and pediatric patients. Safety and usage of c1inhibitor in hereditary angioedema. Rhophylac fda prescribing information, side effects and uses. Riastap, fibrinogen concentrate human, is indicated for the. This document is provided in portable document format pdf. Pharmacovigilance is the science of collecting, monitoring, researching, assessing, and. Ares201477302 15012014 3 foreword directive 200183ec and directive 200182ec specifically requires the european commission in. Official website privigen immune globulin intravenous. Csl behring pharmacovigilance department at 18669156958. Postmarketing safety reports recorded by csl behring from june 1993 to september 20. Human serum albumin is used as the excipient of choice in many pharmaceutical and biotech applications.
Berinert is manufactured by csl behring gmbh and distributed by csl behring llc. Inform your healthcare provider of all medications you are taking and of any medical conditions, especially any history of bloodclotting problems. Csl behring biotherapies are manufactured in stateoftheart facilities under stringent, controlled conditions. Csl behring is a leading global biotech company driven by its promise to save and improve lives. Csl behring s excipient hsa has been successfully used as a medium component cryopreservation and stem cell expansion, a product stabilizer, coatings on medical devices, carrier molecules in.
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